Parker UK TETPOR AIR - Rev 3.5

Parker domnick hunter Validation Document Registered No.
UNCONTROLLED COPY
VALIDATION
GUIDE
TETPOR AIR
Sterilizing grade
Cartridge and Capsule Filters
Validation Document for TETPOR AIR Page 1 of 27 Publication Stock No 179501162

Cartridge and Capsule Filters Revision 3.5
Parker domnick hunter Validation Document Registered No. UNCONTROLLED COPY
Contents
1. INTRODUCTION ..................................................................................................................................... 3
2. QUALITY ASSURANCE ......................................................................................................................... 4
2.1. QUALITY AND ENVIRONMENTAL MANAGEMENT SYSTEMS 4

2.2. MANUFACTURING FACILITIES 4
2.3. MATERIAL CONFORMITY 4
2.4. PRODUCT AND LOT RELEASE CRITERIA 4
2.5. PRODUCT TRACEABILITY 5
2.6. PRODUCT SHELF LIFE 5
3. PRODUCT DESCRIPTION ..................................................................................................................... 6
3.1. MATERIALS OF CONSTRUCTION 6

3.2. PRODUCT CODING 7
3.3. CARTRIDGE ENDCAP CONFIGURATIONS 9
3.4. CAPSULE DIMENSIONS 10
4. PRODUCT SPECIFICATIONS .............................................................................................................. 12
4.1. CARTRIDGE OPERATING DIFFERENTIAL PRESSURES AND TEMPERATURES 12

4.2. CAPSULE OPERATING DIFFERENTIAL PRESSURES AND TEMPERATURES 12
4.3. EFFECTIVE FILTRATION AREA (EFA) 12
4.4. FLOW RATES 13
4.5. AUTOCLAVE LIFE 14
4.6. STEAM STERILIZATION (AUTOCLAVING AND STEAM IN PLACE) 14
4.7. RETENTION 16
4.8. LIQUID BACTERIAL CHALLENGE 16
4.9. DIFFUSIONAL FLOW CORRELATION DATA 17
4.10. WATER INTRUSION CORRELATION DATA 18
4.11. INTEGRITY TESTING DATA FOR DIFFUSIONAL FLOW 19
4.12. RETENTION TO AEROSOLIZED BREVUNDIMONAS DIMINUTA 19
5. CHEMICAL COMPATIBILITY ............................................................................................................... 20
6. CARTRIDGE CLEANLINESS & EXTRACTABLES .............................................................................. 23
6.1. CARTRIDGE CLEANLINESS 23

6.2. EXTRACTABLES 24
7. TESTS FOR BIOCOMPATIBILITY ....................................................................................................... 25
8. CERTIFICATE OF CONFORMANCE ................................................................................................... 26

1. Introduction
Sterilizing grade filters used to sterilize gases that come into contact with food or drug products must conform
to strictly defined quality standards.
This validation guide provides proof of performance of the TETPOR AIR filter cartridges with respect to
bacterial retention and physical performance characteristics such as flow rates and resistance to steam
sterilization. The performance tests conducted for TETPOR AIR products have been designed to guarantee
that sterile gas will continue to be provided even under the most arduous operating conditions.
Guidelines for validation can be sourced from publications issued by the FDA, EMEA, USP, EP, BP, PDA1,
etc. This validation document has been produced with these guidelines in mind to enable the end user to
incorporate this information within their own validation documentation or standard operating procedures for
the process.
The performance of the filter cartridge has been tested in accordance with - and exceeds - the specific
guidelines of PDA Technical Report 40 ‘Sterilizing Filtration of Gases’ (Supplement Volume 58 No.S-1 Jan / Feb
2005). The filter also conforms to ISO 8573-7 - Compressed Air Part 7. Test Methods for viable microbiological
contaminant content.
NOTE
If printed with the banner UNCONTROLLED COPY, this validation document has not been registered.
If you wish to receive amendments and updates automatically, then please contact the department
below or fax this page with your name and address and we will send you a registered copy:
The Quality Assurance Department
Parker Hannifin Manufacturing Ltd
Durham Road, Birtley, Co. Durham, UK, DH3 2SF
Tel: +44 (0)191 4105121
Fax: +44 (0)191 410 5312
E-mail: dhprocess@parker.com
Registered Holder Information

Name: …………………………………………………………
Company: …………………………………………………………
Department: …………………………………………………………
Address: …………………………………………………………
…………………………………………………………
…………………………………………………………
Registered No. …………………………………………………………
Date Issued: …………………………………………………………
Signed …………………………………………………………
1
FDA, EMEA, USP, EP, BP, PDA – Food and Drug Administration, European Medicines Evaluation Agency, United States, European and British
Pharmacopoeia, Parenteral Drug Association.

2. Quality Assurance
Quality is built into all Parker domnick hunter filtration products through a rigorous product design process,
careful selection of suppliers and materials, and manufacture within a highly controlled environment using
validated production technologies in adherence to cGMP.
2.1. Quality and Environmental Management Systems
Parker domnick hunter is certified by Lloyds Register Quality Assurance to:
 BS EN ISO9001 Quality Management Systems

 BS EN ISO14001 Environmental Management Standard
 BS EN ISO13485 Medical Devices
Copies of the original certificates are available upon request.
2.2. Manufacturing Facilities
Parker domnick hunter continues to invest substantially in installation of the latest clean room and
manufacturing technology. Manufacturing systems are validated using statistical methodologies (process,
product and software) and constantly monitored using statistical process control charts. All personnel within
the manufacturing operations are fully trained in cGMP and against competency frameworks to ensure their
suitability to operate within specific manufacturing areas.
2.3. Material Conformity
Parker domnick hunter works closely with suppliers to ensure materials supplied are of a consistently high
quality and also to develop new materials as part of our ongoing product development activity. In addition to
supplier certificates of conformity and analysis, incoming raw materials, including moulded parts, membranes
and supports, and elastomeric seals, are subject to an appropriate level of incoming inspection. This includes
bacterial challenge on each lot of membrane used in the manufacture of sterilizing grade filter cartridges.
2.4. Product and Lot Release Criteria
Prior to shipment all Parker domnick hunter cartridges undergo final product quality control. 100% of testable
products undergo a non-destructive integrity test (diffusional flow). This includes a high volume flush with
water that meets or exceeds the current EP and USP standards for purified water. Products are dried using
HEPA filtered air and sealed in a protective polyethylene bag within the controlled manufacturing environment
prior to final pack and despatch.

2.5. Product Traceability
The product code and type, lot number and unique serial number are printed on all products. Additionally, the
lot number is identified on the protective bag label and the box label within which the product is packed. The
serial number provides complete traceability back to pleated materials used in the manufacture of each
product and the manufacturing processes through the module routing sheet.
Serial number
Serial number
Lot number
Lot number
2.6. Product Shelf Life
The shelf life for TETPOR AIR cartridges is 5 years for cartridges and 3 years for capsules.

3. Product Description
All products within the TETPOR AIR range are fully validated to provide sterile air / gas under worst-case
conditions in a wide range of applications through the food & beverage, dairy and pharmaceutical industries.
This performance has been qualified under worst case condition (sterile gas system flooded with water) using
the current revision of ASTM Standard Test Method F838 for sterilizing liquid filters. Their performance in gas
streams has been qualified for full retention of both bacteria and bacteriophage when tested in accordance
with the recommendations in PDA Technical Report 40 ‘Sterilizing Filtration of Gases’ (Supplement Volume 58
No.S-1 Jan / Feb 2005).
3.1. Materials of construction
All materials meet the FDA requirements as defined in Title 21 Code of Federal Regulations and the BioSafety
Tests as defined in the current USP including the Class VI Plastics Testing.
 Filtration Membrane Polytetrafluoroethylene (PTFE)

 Upstream Support Polypropylene
 Downstream Support Polypropylene
 Inner Core Polypropylene
 Outer Protection Cage Polypropylene
 Endcaps Polypropylene
 Endcap Insert 316 Stainless Steel / Polysulphone (T-Style)
 Standard o-rings Silicone
 Capsule body Polypropylene
 Capsule Vent Seals Silicone

3.2. Product Coding
Product code structures indicate the cartridge sizes, endcap configurations and o-rings that are available
within the product range.
Cartridges
Example ZCMT2/-020C-A 500 mm (20ʺ) 0.2 micron TETPOR AIR filter cartridge, pharmaceutical
grade with ‘C’ style endcap and Silicone o-rings.
ZCMT / -
Length Length Diameter 10ʺ Endcap

Code Code Micron Rating Code Code Variant Ref Code ‘O’ Rings
(mm) (inch) (mm) Style
B 65 25 56 B Dh DOE A Air E EPDM2

020 0.2µm FEP encapsulated
A 125 5 56 C P-7 P
silicone
K 125 5 72 G M-0 V Viton3
1 250 10 72 R S-28 S Silicone
2 500 20 72
DEMI Endcap
3 750 30 72 Code
Style
4 1000 40 72 SK Retrofit
T TRUESEAL
Y DEMI MCY
Z DEMI A&B Std
Small scale DEMICAP capsules
Example ZEMTB-020TT-AN3 B-size 0.2 micron TETPOR AIR filter capsule with tri-clamp
connections supplied non-sterile in packs of 3.
ZEMT / - -
Length Length Micron

Code Code Code Inlet / Outlet Connection Code Variant Ref Code Sterilisation Grade Code Pack No
(mm) (inch) Rating
E 113 4.4 T 1ʺ Tri-clamp A Air N Supplied non-sterile 3 3 per pack

020 0.2µm
B 140 5.5 N ½ʺ NPT male
Optional
A 200 7.9 H ½ʺ hosebarb Code Variant Ref
G Stepped hosebarb
No Vent
N
M ¼ʺ NPT male B-Size Only
Q Walther QC
R Grommel / QC
V 3/8ʺ NPT female
2
EPDM – Ethylene Polypropylene Diene Monomer Rubber
3
Viton is a registered trademark of DuPont Dow Corporation

Large scale MURUS capsules
Example ZLMTK-020TT-ANL K-size 0.2 micron TETPOR AIR filter capsule with tri-clamp
connections supplied non-sterile with inline design and silicone o-rings.
Code Accessory
ZLMT - - -
S Silicone
E EPDM4
V VitonTM5
Length Length Micron

Code Code Code Inlet / Outlet Connection Code Variant Ref Code Sterilisation Grade Code Design
(mm) (inch) Rating
K 125 5 A ¾ʺ tri-clamp A Air N Supplied non-sterile L Inline

020 0.2µm
1 250 10 B 1 ½ʺ tri-clamp T T-port
Streamline
2 500 20 D 1ʺ hosebarb M
Valve
3 750 30 T 1ʺ tri-clamp
H ½ʺ hosebarb
Syringe filters
Example ZSMT050-020GG-ANS025 50 mm TETPOR AIR syringe filter, 0.2 micron with stepped
hosebarb connections supplied non-sterile in packs of 25
ZSMT - -
Diameter
Code Code Micron Rating Code Inlet / Outlet Connection Code Variant Ref Code Sterilisation Grade Code Options Code Pack No
(mm)
050 50 G Stepped hosebarb A Air N Supplied non-sterile S Standard 025 25 per box
020 0.2µm
L 1/8ʺ NPT male
4
EPDM – Ethylene Propylene Diene Momomer Rubber.
5
Viton is a registered trademark of DuPont Dow Corporation.

3.3. Cartridge Endcap Configurations

3.4. Capsule Dimensions
Dimensions shown are typical lengths for 1½ʺ Tri-Clamp. Further dimensions are available from Parker
domnick hunter.

DEMICAP Inlet / Outlet Connection Styles
MURUS Inlet / Outlet Connection Styles

4. Product Specifications
4.1. Cartridge Operating Differential Pressures and Temperatures
To obtain representative maximum differential pressures the filter cartridge membrane was first wet out in
60:40v/v IPA:Water then water was flowed through representative 10 inch cartridges at temperature to achieve
the required differential pressure for 30 minutes.
The recommended continuous maximum differential operating pressure and temperature is shown below.
Temperature Differential Pressure

Cartridges
°C °F bar psi
60 140 3.00 43.5
4.2. Capsule Operating Differential Pressures and Temperatures
DEMICAP
The TETPOR AIR range of DEMICAP capsules can be operated up to 40°C (104°F) at line pressures up to
5.0 barg (72psig)
MURUS
The TETPOR AIR range of MURUS capsules can be operated up to 25°C (77°F) at line pressures of 5.5
barg (79.7 psig) or up to 60°C (140°F) at line pressures of 2.8 barg (40.6 psig).
4.3. Effective Filtration Area (EFA)
Product Size Surface Area (m2) Surface Area (ft2)
Syringe 0.015 0.1
E 0.07 0.64
B 0.14 1.29
A 0.27 2.69
K 0.36 3.87
10 0.77 8.28
20 1.54 16.58
30 2.31 24.86

4.4. Flow Rates
Cartridge flow rates were determined for filters from three separate lots.
Air Flow Characteristics for TETPOR Air

Air Flow Characteristics for TETPOR AIR A-Size
A-SizeCartridges
Cartridges
(mbar)
1200.00
0 barg
Pressure (mbar)
1000.00 2 barg
DifferentialPressure
800.00
600.00
400.00
Differential
200.00
0.00
0.00 200.00 400.00 600.00 800.00 1000.00 1200.00
Flow Flow
(Nm3/h) for
(Nm3/h) forair
air @ 21ºC
@ 21°C
Air Flow Characteristics for 250mm (10")

TETPOR AIR Cartridges
1200
Differential Pressure (mbar)
0 barg
1000
2 barg
800
600
400
200
0
0 500 1000 1500 2000 2500
Flow (Nm3/h) for air @ 21ºC

4.5. Autoclave life
The autoclave life of capsules was determined using a porous load cycle.
Cycle Temp Cycle Time
Product Format Number of Cycles (minutes at
°C °F temperature)
Cartridges 142 288 120 30
DEMICAP Capsules 130 266 100 30
MURUS Capsules 130 266 5 30
To maximize cartridge and capsule life, a slow exhaust cycle is recommended.
4.6. Steam Sterilization (Autoclaving and Steam in Place)
The steam life of cartridges was determined using the 1 hour Steam in Place (SIP) cycle which replicates
extreme conditions. This includes a combination of steaming for 30 minutes at temperature followed by rapid
cooling with ambient temperature compressed air for 30 minutes.
Steam Cycle Profile for Sterile Gas Products

142 deg C steam for 30 mins followed by 30 mins air cool
150
140
130
120
110
Temperature (°C)
100
90
80
70
60
50
40
30
20
10
0
0 15 30 45 60 75 90 105 120 135
Time (min)
SIP Temp Cycle Time

Product Format Number of Cycles (minutes at
°C °F temperature)
Cartridges 142 288 120 30
Capsules Do not steam in place
It should be noted that the number of times the temperature is cycled from ambient to the sterilization
temperature rather than the time at temperature determines the lifetime of the cartridge in steam.
To maximize the life of the cartridge, the differential pressure across the cartridge should not exceed 0.30 bar
(4.4 psi) at 142°C (288°F). For new applications it is recommended that the Parker domnick hunter guidance
for the method of steam sterilization be followed.

The resistance to steam sterilization was determined by evaluating three production batches of 10 inch and
A-Size cartridges. A representative sample is shown below.
Integrity Test Values post SIP @ 142oC

Cartridge 0 cycles 132 cycles
Batch Serial No
Size
Diff flow B.pt Diff flow B.pt
(mL/min) (mbar) (mL/min) (mbar)
N613840 0.4 1632 5.2 1360

1 10 Inch N613831 0.4 1643 11.7 1347
N613827 0.4 1670 10.7 1371
N615605 7.7 1564 15.5 1301
2 10 Inch N615612 5.7 1519 5.8 1277
N615613 8.6 1561 12.6 1334
EH6687 5.0 1620 11.8 1361
3 10 Inch EH6697 9.1 1700 6.9 1406
EH6682 14.1 1661 9.8 1387
A325745 0.3 1811 0.8 1572
1 A A325738 0.1 2635 0.4 1490
A325742 0.1 1775 0.4 1540
A367866 0.4 1752 0.6 1427
2 A A367867 0.5 1735 1.9 1421
A367868 2.2 1733 2.1 1418
A375182 0.7 1696 0.7 1394
3 A A375177 1.2 1634 1.1 1327
A375174 1.5 1719 0.9 1349
NOTE: Maximum allowable diffusional flow for a 10 inch TETPOR AIR is 17.7mL/min
Maximum allowable diffusional flow for an A-Size TETPOR AIR is 6.0mL/min
Minimum bubble point for TETPOR AIR is 1.0 bar.
Conclusion
The TETPOR AIR range of filter cartridges can be steam sterilized up to 120 cycles at 142 oC (266oF), which
includes a 10% safety factor.

4.7. Retention
The retention of a sterilizing grade filter cartridge that may be used in the manufacture of a drug product needs
to be correlated to both a liquid and gas phase challenge. Tests in the liquid phase are conducted because
they are seen as worst case i.e. if the compressed air system becomes flooded with water / condensate the
filter will still maintain sterility of the process. This testing is a required when the process air comes into contact
with the final drug product i.e. vent filters in sterile filling lines and compressed air used in BFS equipment.
The current revision of the industry recognized test procedure ASTM F838 ‘Standard Test Method for
Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration’6 is used in this case.
To ensure the filter is capable of sterilizing in the gas phase, representative samples were also subjected to
aerosol bacterial and bacteriophage challenges. These tests were conducted in line with the guidelines
published in PDA Technical Report 40 ‘Sterilizing Filtration of Gases’ (Supplement Volume 58 No.S-1 Jan / Feb
2005).
4.8. Liquid Bacterial Challenge
Liquid Bacterial Challenge Schematic
Under these test conditions, the test filter is challenged with a minimum of 107 viable Brevundimonas diminuta
(ATCC 19146) per square centimetre of effective filtration area. Any organisms that pass through the test
filter are collected and cultured on the surface of analytical discs. In this way colonies may be counted and
bacterial species identified. The filter retention is quantified by expressing the filter’s efficiency to remove the
challenge organism from the challenge suspension as a Log Reduction Value (LRV).
LRV = Log10 (Number of organisms in the challenge/Number of organisms in the filtrate)
6
Previous reference to the guidance document Microbial Evaluation of Filters for Sterilizing Liquids, HIMA Document No. 3 Vol. 4, April 1982, referred
to in USP<1211> Sterilization by Filtration has been superseded by the equivalent ASTM F838.

4.9. Diffusional Flow Correlation Data
The correlation between diffusional flow and bacterial challenge for TETPOR AIR cartridges is shown in the
table below. This data shows that a 250mm (10ʺ) TETPOR AIR filter exhibiting a diffusional flow of ≤17.7
mL/min when completely wet with 60:40v/v IPA:Water at a test pressure of 0.8 barg (11.6psig) at 20oC (68oF)
will produce a sterile filtrate.
Filter type: ZCMT1/020C-A TETPOR AIR 0.2µm 10” cartridge
Challenge organism: Brevundimonas diminuta (ATCC 19146)

Diffusional Flow
(Air in 60:40v/v IPA:Water) Challenge Organisms
Serial No. LRV7
@ 0.80 barg (11.6 psig) Level Passed
mL/min
N561333 2.9 1.4 x 1011 0 11.1

N560087 3.9 1.8 x 1011 0 11.2
N561311 4.6 1.2 x 1011 0 11
N586194 4.9 2.2 x 1011 0 11.3
N558182 5.8 1.2 x 1011 0 11
N567597 6.5 2.0 x 1011 0 11.3
N564406 6.8 1.2 x 1011 0 11
EE1580 8.3 4.4 x 1011 0 11.6
N558164 8.8 1.0 x 1011 0 11
N608362 9.3 3.6 x 1011 0 11.5
N567607 10.2 1.2 x 1011 0 11
N567613 11.1 1.4 x 1011 0 11.1
N557706 11.7 1.6 x 1011 0 11.2
EE1572 12.1 3.8 x 1011 0 11.5
EF2309 13.0 6.7 x 1011 0 11.8
EF6181 13.9 2.4 x 1011 0 11.3
EE1634 13.9 3.1 x 1011 0 11.4
EE6156 14.9 2.8 x 1011 0 11.4
N596854 14.9 9.5 x 1010 0 10.9
N596900 15.8 3.5 x 1011 0 11.5
EE5524 15.8 3.0 x 1011 0 11.4
N596897 16.7 4.0 x 1011 0 11.6
EE6253 16.7 2.5 x 1011 0 11.3
N596898 17.7 2.3 x 1011 0 11.3
Conclusion
A maximum diffusional flow of 17.7 mL/min for a 60:40v/v IPA:Water wetted 10ʺ TETPOR AIR filter cartridge
provides complete assurance of a sterile effluent.
7
Where Organisms passed = 0, LRV is stated as greater than. TNTC : Too Numerous To Count

4.10. Water Intrusion Correlation Data
The correlation between water intrusion and bacterial challenge for TETPOR AIR cartridges is shown in the
table below. This data shows that a 250 mm (10ʺ) TETPOR AIR filter exhibiting a water intrusion value of
≤15.3 mL/10 min or water flow value of 4370 µL/10min at a test pressure of 2.5 barg (36.3 psig) at 20oC (68oF)
will produce a sterile filtrate.
Filter type: ZCMT1/020C-A TETPOR AIR 0.2µm 10” cartridge
Challenge organism: Brevundimonas diminuta (ATCC 19146)
Water Intrusion Water Flow Challenge

Organisms
Serial No. @ 2.50 barg (36.3 psig) @ 2.50 barg (36.3 psig) Level LRV8
Passed
mL/10min µL/10min (x 1011)
N613856 7.0 1991 3.6 x 1011 0 11.3

N613843 7.1 2029 3.0 x 1011 0 11.5
N613819 7.1 2030 3.0 x 1011 0 11.5
N613837 7.1 2030 2.7 x 1011 0 11.4
N613855 7.1 2031 3.4 x 1011 0 11.5
N613829 7.1 2032 3.7 x 1011 0 11.6
N613865 7.1 2040 3.5 x 1011 0 11.5
N613846 7.3 2078 1.9 x 1011 0 11.3
N613828 7.3 2082 2.6 x 1011 0 11.6
N613824 7.4 2110 3.5 x 1011 0 11.3
N613854 7.5 2135 2.4 x 1011 0 11.4
N613866 7.5 2136 2.4 x 1011 0 11.4
EG3162 7.5 2137 1.4 x 1011 0 11.1
N613864 7.5 2139 1.4 x 1011 0 11.1
N613822 7.7 2196 2.3 x 1011 0 11.4
E631163 7.9 2256 4.1 x 1011 0 11.6
N613825 10.8 3080 5.4 x 1011 0 11.8
N613847 14.5 4144 4.1 x 1011 0 11.6
N613820 15.3 4370 5.3 x 1011 0 11.7
Conclusion
A maximum water intrusion value of 15.3 mL/10 min for a 10ʺ TETPOR AIR filter cartridge provides complete
assurance of a sterile effluent.
8
Where Organisms passed = 0, LRV is stated as greater than.

4.11. Integrity Testing Data for Diffusional Flow
The following integrity test limits have been determined from the 10 inch correlation data. Limits for other
sizes have been calculated directly from effective filtration area ratios for each variant. Diffusional flow and
bubble point values are given for cartridges wetted in 60:40v/v IPA : Water solution using air as the test gas.
Diffusional
Minimum
Micron Rating Flow Test Maximum Diffusional Flow (mL/min)
Bubble Point9
Pressure
bar psi bar psi 10” K A B E

0.2µm
1.0 14.5 0.80 11.6 17.7 8.3 6.0 3.0 1.5
Water Intrusion
Maximum Water Intrusion (mL/10min)
Test Pressure
bar psi 10” K A B E
2.50 36.3 15.3 7.2 5.3 2.6 1.3
Water Intrusion
Maximum Water Flow (µL/10min)10
Test Pressure
bar psi 10” K A B E
2.50 36.3 4370 2060 1514 742 371
4.12. Retention to Aerosolized Brevundimonas diminuta
Tests have shown that TETPOR AIR filters are fully retentive to aerosolized Brevundimonas diminuta (ATCC
19146) bacteria when challenged with a total of 2x1011 cfu11 over a 1-hr test at the rated flow of the cartridge.
PDA Technical Report 40 ‘Sterilizing Filtration of Gases’ states that, due to the mechanisms of retention,
bacterial challenge testing in the liquid phase represents “worst-case” conditions for a filter. Therefore, aerosol
bacterial challenge test data is included for information only.
9
Parker domnick hunter does not recommend the use of bubble point as an integrity test method for cartridges, but values are given for use as an
indicator of product integrity.
10
Values given for Water Flow (µL/10mins) and Water Intrusion (mL/10mins) are expressions of the same parameter, the first being the actual change
in water volume during the test, the second being the pressurized gas volume change (expressed at atmospheric pressure) as a result of this water
flow.
11
Colony forming units

5. Chemical Compatibility
The following data is indicative of TETPOR AIR cartridge compatibility with a range of chemicals at ambient
temperature and 72 hour exposure. However it is recommended that specific process conditions are
reviewed with your local Parker domnick hunter representative.
HIGH FLOW TETPOR

VENT AUTOCLAVE
VENTAUTOCLAVE
HIGH FLOW BIO-X
HIGH FLOW BIO-X
SILICONE o-ring
TETPOR LIQUID
PROCLEAR GP
PROCLEAR GF
PROCLEAR PP
TETPOR PLUS
PREPOR GFA
TETPOR H.T.
VITON o-ring
PROPOR MR
PROPOR SG
PROPOR HC
PROPOR BR
TETPOR AIR
EPDM o-ring
PROPOR LR
HIGH FLOW
HIGH FLOW
HIGH FLOW
TETPOR II
BIO-X II
Acetic acid 3.5N C C C C C C C C C C C C C C C C C C C C C
Acetic acid 8.75N C C - C C C C C C C - - - - - C C C LC LC NC
Acetic acid conc.17.5N C C - C C C C C C C - - - - - C C C LC NC NC
Acetone C C - C C C C C C C NC NC NC NC NC C C C NC NC NC
Acetonitrile C C - LC C C C C LC LC - - - - - C C C NC NC NC
Acidbrite 4 (Diversey) 3.0%v/v - - - C - - - C C C - - - - - - - - C C C
Ammonium Hydroxide 8N C C C C C C C C C C LC LC LC LC LC C C C C C C
Ammonium Oxalate 0.07N C C C C C C C C C C - - - - - C C C C C C
Amyl Acetate C C C LC C C C C LC LC LC LC LC LC LC C C C NC NC LC
Aqueous Ammonia 15.5N C C C LC C LC C C LC LC LC LC LC LC LC C C C C C C
Benzyl Alcohol C C C NC C C C NC NC NC - - - - - C C C C C C
Benzyalkonium Chloride 0.1% C C C C C C C C C C - - - - - C C C C C C
Boric acid,saturated C C C C C C C C C C - - - - - C C C C C C
Butan-1-ol C C C C LC LC LC C C C C C C C C NC NC NC C C C
Butan-2-ol C C C C C C C C C C C C C C C C C C LC C C
Carbon Tetrachloride C C C NC C C C NC NC NC - - - - - NC NC NC NC C NC
Chloroform C C C NC C C C NC NC NC NC NC NC NC NC NC NC NC NC LC NC
Cyclohexane C C C NC - - - NC NC NC - - - - - LC LC LC NC NC NC
1,4 – Dioxane C C C LC C C C C LC LC - - - - - C C C NC NC NC
Diverflow (Diversey) 3%v/v - - - NC - - - C NC NC C C C C C - - - C C LC
Diversey 212G 0.6%v/v - - - C - - - C C C - - - - - - - - C C C
Divosan Forte 0.5%v/v - - - C - - - C C C C C C C C - - - C C C
Divosan XT 1%v/v - - - C - - - C C C - - - - - - - - C C C
Ethanol C C C C C - C C C C C C C C C C C C C C LC
Ethanol 45% - - - C - - - C C C C C C C C C C C C C C
Ethyl Acetate LC LC LC LC LC LC LC LC LC LC NC NC NC NC NC LC LC LC C NC LC
Formaldehyde 0.3% C C C C C C C C C C C C C C C C C C C C C
Formaldehyde 37% C C C C C C C C C C - - - - - C C C C C C
Formic acid conc. C C C NC C C C C NC NC - - - - - C C C C NC NC
Glycerol C C C C C C C C C C C C C C C C C C C C C
Hexane C C C - C C C NC - - - - - - - - - - NC NC NC

HIGH FLOW TETPOR

VENT AUTOCLAVE
VENTAUTOCLAVE
HIGH FLOW BIO-X
HIGH FLOW BIO-X
SILICONE o-ring
TETPOR LIQUID
PROCLEAR GP
PROCLEAR GF
PROCLEAR PP
TETPOR PLUS
PREPOR GFA
TETPOR H.T.
VITON o-ring
PROPOR MR
PROPOR SG
PROPOR HC
PROPOR BR
TETPOR AIR
EPDM o-ring
PROPOR LR
HIGH FLOW
HIGH FLOW
HIGH FLOW
TETPOR II
BIO-X II
Hydrochloric acid 1N - - - C - - - C C C C C C C C C C C C C C
Hydrochloric acid conc. - - - NC - - - C NC NC - - - - - C C C NC NC NC
Hydrochloric acid conc.13% C C C - C C C - - - - - - - - - - - NC NC NC
Hydrogen Peroxide C C C - - - - C - - - - - - - - - - C C C
Hydrogen Peroxide 10%
- - - C - - - C C C C C C C C C C C C C C
Volume
Hydrogen Peroxide 100%
- - - C C C C C C C - - - - - C C C C C C
Volume
Methanol C C C C C C C C C C C C C C C C C C C NC C
Methyl-Iso-Butylketone C C C C C C C C C C NC NC NC NC NC C C C NC NC LC
Methylene Chloride @ 40°C - - - LC - - - LC LC LC - - - - - - - - - - -
Nitric acid 2N 14.4% C C C C C C C C C C C C C C C C C C LC C C
Nitric acid 15.8N C C C NC C NC C C NC NC - - - - - C C C NC NC NC
Ozone - - - - - - - - - - NC NC NC NC NC - - - - - -
Paraffin yellow LC LC LC LC C C C C LC LC - - - - - C C C NC C NC
Pentane C C C LC - - - LC LC LC - - - - - LC LC LC NC C NC
Peracetic acid 0.5% (10 wk test) - - - - C C C - - - - - - - - - - - C C C
Peracetic acid 4% C C C C C C C C C C C C C C C C C C C C C
Perchloroethylene - - - - - - - - - - NC NC NC NC NC - - - - - -
Petroleum spirits - - - NC C C C NC NC NC - - - - - LC LC LC NC C NC
Phenol (aq) 0.5N C C C - NC - NC - - - - - - - - - - - - - -
Phenol 5% - - - C - - - C C C - - - - - C C C C C C
Phenol 0.25% - - - C - - - C C C - - - - - C C C C C C
Polyethylene Glycol 600 LC LC LC NC C C C LC NC NC NC NC NC NC NC - - - - - -
Polyglycol 2000-E - - - - - - - - - - - - - - - - - - C C C
Potassium Dichromate 0.1N C C C C C C C C C C - - - - - C C C C C C
Potassium Iodine 0.6N C C C C C C C C C C - - - - - C C C C C C
Potassium Hydroxide 10N C C C NC C C C C NC NC LC LC LC LC LC C C C C C C
Potassium Permanganate 0.1N C C C NC C LC C C NC NC C C C C C C C C C C C
Propan-1-ol C C C NC C C C C NC NC C C C C C C C C C C LC
Propan-2-ol C C C NC C C C C NC NC C C C C C C C C C C LC
Propan-2-ol, 60:40 H2O C C C NC C C C C NC NC C C C C C C C C C C C
Pyridine C C C NC C C C C NC NC NC NC NC NC NC C C C C NC C
Sodium Chloride 0.5N C C C C C C C C C C C C C C C C C C C C C
Saline Lactose Broth C C C C C C C C C C C C C C C C C C C C C
Sodium Hydroxide 1N 4% NC NC NC C C C C C C C C C C C C C C C C C C
Sodium Hydroxide 7N 28% NC NC NC NC C C C C NC NC NC NC NC NC NC C C C C C LC

Sodium Hypochlorite (14%
C C C C C C C C C C C C C C C C C C C C C
Free Cl2 )

HIGH FLOW TETPOR

VENT AUTOCLAVE
VENTAUTOCLAVE
HIGH FLOW BIO-X
HIGH FLOW BIO-X
SILICONE o-ring
TETPOR LIQUID
PROCLEAR GP
PROCLEAR GF
PROCLEAR PP
TETPOR PLUS
PREPOR GFA
TETPOR H.T.
VITON o-ring
PROPOR MR
PROPOR SG
PROPOR HC
PROPOR BR
TETPOR AIR
EPDM o-ring
PROPOR LR
HIGH FLOW
HIGH FLOW
HIGH FLOW
TETPOR II
BIO-X II
Sodium thiosulphate 0.1N C C C C C C C C C C - - - - - C C C C C C
Sulphuric acid 1N C C C LC C C C C LC LC C C C C C - - - C C C
Sulphuric acid conc. NC NC NC LC LC NC LC LC LC LC NC NC NC NC NC LC LC LC - - -
Sulphurous acid - - - - - - - - - - NC NC NC NC NC - - - - - -
Toluene NC NC NC - NC NC NC NC - - NC NC NC NC NC - - - NC LC NC
1,1,1 Trichloroethane - - - - - - - - - - - - - - - - - - - - -
1,1,2 Trichloroethane C C C LC C LC C LC LC LC NC NC NC NC NC LC LC LC NC LC LC
Trichloroacetic Acid 80% - - - LC - - - C LC LC - - - - - C C C NC LC NC
Trichloroacetic Acid 5N C C C - C C C - - - - - - - - - - - ---
Toluene - - - NC - - - - NC NC - - - - - - - - NC LC NC
Xylene LC LC LC NC LC LC LC NC NC NC LC LC LC LC LC NC NC NC C LC NC
Chemical Compatibility User Instructions and Notes
 The chemicals are arranged in alphabetical order using their most common or trade names. If the
chemical in question does not appear to be listed, it may be found elsewhere in the table under a
pseudonym, in particular its IUPAC12 name.
 Please note:
− Any product that has limited compatibility (LC) at ambient temperatures should not be used at
a higher temperature.
− The list of compatibilities does not take into account any synergistic effects of more than one
chemical present in the solution to be filtered.
12
International Union of Pure and Applied Chemistry

6. Cartridge Cleanliness & Extractables

TETPOR AIR filters must meet stringent standards to be certified pharmaceutical (P) grade product by Parker
domnick hunter. One aspect of this is to confirm levels of potential contaminants that may be added to a
process stream by the addition of the filter cartridge. Although this requirement is normally associated with
sterile liquid filters, a number of tests have been conducted to demonstrate the cleanliness of the product
when in contact with some common fluids to prove acceptability in applications such as vent filtration non WFI
holding tanks.
6.1. Cartridge Cleanliness
Bacterial Endotoxins: 10ʺ Cartridges
Analysis of bacterial endotoxin content from purified water samples after flowing through three autoclaved
250mm (10ʺ) TETPOR AIR cartridges is listed below. Testing was conducted in accordance with USP<85>
methodology. The levels shown are the concentrations present in 1000mL samples of initial filtrate effluent.
Bacterial
Cartridge Serial Number Endotoxins Test Result
USP <85>
N613852 0.0149 EU/mL Pass
N615592 0.0342 EU/mL Pass
EH6676 0.00356 EU/mL Pass
Test results indicate that the bacterial endotoxin content of the first litre of filter effluent is below the maximum
specified test limit of <0.25 EU/mL in each case.
Bacterial Endotoxins: A-Size Demi Cartridges
Analysis of bacterial endotoxin content from purified water samples after flowing through three autoclaved A-
Size (5ʺ) TETPOR AIR demi cartridges is listed below. Testing was conducted in accordance with USP<85>
Bacterial
Cartridge Serial Number Endotoxins Test Result
USP <85>
A325733 0.00100 EU/mL Pass
A367889 0.00148 EU/mL Pass
A375169 0.00234 EU/mL Pass
Test results indicate that the bacterial endotoxin content of the first litre of filter effluent is below the maximum
specified test limit of <0.25 EU/mL in each case.
Particle Shedding: 10ʺ Cartridges

Analysis of particulate content from purified water samples after flowing through three autoclaved 250mm
(10ʺ) TETPOR AIR cartridges is listed below. Testing was conducted in accordance with USP<788>
Particles For
Cartridge Serial Number Injection
USP <788>
N613852 PASS
N615592 PASS
EH6676 PASS
Test results indicate that the particulate content of the first litre of filter effluent is below the maximum specified
test limit of fewer than 25 particles of 10µm to 20µm in size per millilitre and fewer than 3 particles of 25µm to
100µm in size per millilitre in each case.
Particle Shedding: A-Size Demi Cartridges
Analysis of particulate content from purified water samples after flowing through three autoclaved A-Size (5ʺ)
TETPOR AIR demi cartridges is listed below. Testing was conducted in accordance with USP<788>
Particles For
Cartridge Serial Number Injection
USP <788>
A325733 PASS
A367889 PASS
A375169 PASS
Test results indicate that the particulate content of the first litre of filter effluent is below the maximum
specified test limit of fewer than 25 particles of 10µm to 20µm in size per millilitre and fewer than 3 particles
of 25µm to 100µm in size per millilitre in each case.
6.2. Extractables
All pharmaceutical grade filters are designed and manufactured to yield a minimum of extractables. Testing
of a purified water filtrate with TETPOR AIR is documented below.

Non-volatile Extractables: 10ʺ Cartridges
Analysis of non-volatile extractables (by weight) recovered from purified water samples after flowing through
three autoclaved 250mm (10ʺ) TETPOR AIR cartridges is listed below. Testing was conducted in accordance
with USP <661> methodology. The levels shown are the quantities present in 1000mL samples of initial filtrate
effluent.
Non-Volatile
Cartridge Serial Number Extract Test Result
USP <661>
N613835 6 mg Pass
N615614 0 mg Pass
EH6675 3 mg Pass
Test results indicate that the non-volatile extractable content of the first litre of filter effluent is below the
maximum specified test limit of <15mg in each case.
Non-volatile Extractables: A-Size Demi Cartridges
Analysis of non-volatile extractables (by weight) recovered from purified water samples after flowing through
three autoclaved A-Size (5ʺ) TETPOR AIR demi cartridges is listed below. Testing was conducted in
accordance with USP <661> methodology. The levels shown are the quantities present in 500mL samples of
initial filtrate effluent.
Non-Volatile
Cartridge Serial Number Extract Test Result
USP <661>
A325730 1 mg Pass
A367890 14 mg Pass
A375168 11 mg Pass
Test results indicate that the non-volatile extractable content of the first litre of filter effluent is below the
maximum specified test limit of <15mg in each case.
7. Tests for Biocompatibility

An independent research establishment has assessed the biological safety associated with the use of
TETPOR AIR filters designed for processing pharmaceutical products.
The materials used in the construction of TETPOR AIR products meet the requirements of the current USP
<88> Biological Reactivity tests at Plastics Class VI – 121oC.

8. Certificate of Conformance
To certify that Parker domnick hunter’s TETPOR AIR filter products meet the highest pharmaceutical quality
and performance requirements, a Certificate of Conformance is issued.

Documentation Approval Section
Q.A. Approval
Approved By: Martin Newman
Title: Senior Quality Engineer
Date: October 2017
Technical Approval
Approved By: Andrew Kelly
Title: Product Manager (Life Science)
Date: October 2017
Parker Hannifin Manufacturing Ltd.

Durham Road, Birtley, Co. Durham
England, UK. DH3 2SF
Tel: +44 (0)191 4104450
Fax: +44 (0)191 4105312
E-mail: dhprocess@parker.com
Website: www.parker.com/processfiltration
Parker domnick hunter has a policy of continuous product development and although the Company reserves the right to change specification, it
attempts to keep customers informed of any alterations. This publication provides generic validation information only and customers are requested to
contact the Process Division for detailed information and advice on a product’s suitability for specific applications.
Copyright Parker domnick hunter 2017


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Parker domnick hunter Validation Document Registered No.

Validation Document for TETPOR AIR Page 1 of 27 Publication Stock No 179501162

2. QUALITY ASSURANCE ......................................................................................................................... 4

2.1. QUALITY AND ENVIRONMENTAL MANAGEMENT SYSTEMS 4

3. PRODUCT DESCRIPTION ..................................................................................................................... 6

3.1. MATERIALS OF CONSTRUCTION 6

4. PRODUCT SPECIFICATIONS .............................................................................................................. 12

4.1. CARTRIDGE OPERATING DIFFERENTIAL PRESSURES AND TEMPERATURES 12

5. CHEMICAL COMPATIBILITY ............................................................................................................... 20

6. CARTRIDGE CLEANLINESS & EXTRACTABLES .............................................................................. 23

6.1. CARTRIDGE CLEANLINESS 23

7. TESTS FOR BIOCOMPATIBILITY ....................................................................................................... 25

8. CERTIFICATE OF CONFORMANCE ................................................................................................... 26

Validation Document for TETPOR AIR Page 2 of 27 Publication Stock No 179501162

Registered Holder Information

Registered No. …………………………………………………………

Date Issued: …………………………………………………………

Validation Document for TETPOR AIR Page 3 of 27 Publication Stock No 179501162

2.1. Quality and Environmental Management Systems

Parker domnick hunter is certified by Lloyds Register Quality Assurance to:

 BS EN ISO9001 Quality Management Systems

2.2. Manufacturing Facilities

2.3. Material Conformity

2.4. Product and Lot Release Criteria

Validation Document for TETPOR AIR Page 4 of 27 Publication Stock No 179501162

2.5. Product Traceability

2.6. Product Shelf Life

Validation Document for TETPOR AIR Page 5 of 27 Publication Stock No 179501162

3.1. Materials of construction

 Filtration Membrane Polytetrafluoroethylene (PTFE)

Validation Document for TETPOR AIR Page 6 of 27 Publication Stock No 179501162

3.2. Product Coding

Length Length Diameter 10ʺ Endcap

B 65 25 56 B Dh DOE A Air E EPDM2

1 250 10 72 R S-28 S Silicone

Z DEMI A&B Std

Small scale DEMICAP capsules

Length Length Micron

E 113 4.4 T 1ʺ Tri-clamp A Air N Supplied non-sterile 3 3 per pack

V 3/8ʺ NPT female

Validation Document for TETPOR AIR Page 7 of 27 Publication Stock No 179501162

Large scale MURUS capsules

Length Length Micron

K 125 5 A ¾ʺ tri-clamp A Air N Supplied non-sterile L Inline

Validation Document for TETPOR AIR Page 8 of 27 Publication Stock No 179501162

3.3. Cartridge Endcap Configurations

Validation Document for TETPOR AIR Page 9 of 27 Publication Stock No 179501162

3.4. Capsule Dimensions

Validation Document for TETPOR AIR Page 10 of 27 Publication Stock No 179501162

DEMICAP Inlet / Outlet Connection Styles

MURUS Inlet / Outlet Connection Styles

Validation Document for TETPOR AIR Page 11 of 27 Publication Stock No 179501162

4.1. Cartridge Operating Differential Pressures and Temperatures

Temperature Differential Pressure

60 140 3.00 43.5

4.2. Capsule Operating Differential Pressures and Temperatures

4.3. Effective Filtration Area (EFA)

Product Size Surface Area (m2) Surface Area (ft2)